Florbetaben Phase IIb Trial (diagnostic confidence add-on)
Phase IIb clinical trial of florbetaben (BAY 94-9172) amyloid PET in probable Alzheimer's disease and unimpaired controls, with an add-on questionnaire study on diagnostic confidence (Schipke et al. 2012)
Amyloid PET with florbetaben in people with probable Alzheimer's disease and cognitively unimpaired controls, acquired in a phase IIb diagnostic trial and used to study how scan results change referring physicians' diagnostic confidence. 272 people. The images are not shared.
Overview
This entry covers the participants of a phase IIb diagnostic trial of florbetaben (BAY 94-9172), an [18F] tracer that binds amyloid plaque, as reported by Schipke and colleagues in 2012. Their add-on study asked the physicians who had referred each participant how confident they were in the clinical diagnosis before the scan, how the florbetaben result compared with it and whether it would change patient management. The PET images themselves have not been released; only the paper and a figshare record with an erratum and supplementary tables are public.
Composition
The full phase IIb analysis set held 272 people: 147 with probable Alzheimer's disease by NINCDS-ADRDA criteria (74 men, 73 women, mean age 73.9 years, mean MMSE 23.0) and 125 cognitively unimpaired controls (73 men, 52 women, mean age 70.7 years, mean MMSE 29.4). All controls had a CDR of 0; the patients had CDR 0.5 (60), 1 (77) or 2 (10). Referring physicians returned questionnaires for 121 patients and 80 controls. Centres in Australia, Germany, Japan and Switzerland took part in the questionnaire study.
Acquisition
Every participant underwent brain PET with florbetaben. Scanner models, acquisition timing and reconstruction settings are not stated in the public parts of the sources.
Annotations
Scans were read visually and graded with the brain amyloid plaque load (BAPL) score as normal, minor plaque or significant plaque. Among the questionnaire cases, 18% of the scans of patients with probable Alzheimer's disease were read as negative and 18% of the control scans as positive, and the abstract reports increased diagnostic confidence in 80%.
Known limitations
- No images, reads or participant-level data are available, and no access route is published.
- The full text of the paper is behind a paywall; the numbers here come from its abstract and its openly licensed supplement.
- The trial registration number is not given in the public sources, so this entry is not linked to a registry record.
- The supplement lists the questionnaire countries but not the number of centres or questionnaires per country.
Cohort
Aggregate numbers from the sources below. Bars are relative to the 272 subjects.
Sex
- Female 125 46%
- Male 147 54%
Supplementary Table 1 in Karger figshare record 5241433, erratum and supplementary material of Schipke et al. 2012 (CC BY 4.0)
Condition
Groups can overlap
- Alzheimer's disease 147 54%Age mean 73.9 ± 7.8
- Healthy control 125 46%Age mean 70.7 ± 6.6
Supplementary Table 1 in Karger figshare record 5241433, erratum and supplementary material of Schipke et al. 2012 (CC BY 4.0)
PET tracer
- [18F]florbetaben 272 100%
Supplementary Table 1 in Karger figshare record 5241433, erratum and supplementary material of Schipke et al. 2012 (CC BY 4.0)
Condition by sex
Reported cross table. A dot marks a cell the source does not give.
| Female | Male | |
|---|---|---|
| Alzheimer's disease | 73 | 74 |
| Healthy control | 52 | 73 |
Supplementary Table 1 in Karger figshare record 5241433, erratum and supplementary material of Schipke et al. 2012 (CC BY 4.0)
License and access
Our reading of the license, not legal advice. Before you use the data, read the original license and confirm that your use is allowed. We take no responsibility for how you use a dataset. Full disclaimer
The data are not available outside the institution or study that holds them
No published license or data use terms
The data holder has published no license and no data use terms. Any use, sharing or commercial right has to be agreed with the data holder, and nothing can be assumed to be allowed. Default copyright and data protection law still apply.
No data sharing route for the PET images is published. The figshare record that holds the erratum and the supplementary tables is licensed CC BY 4.0, but it contains no images.
What you can do
- Commercial use Not stated
- Not stated
- Train ML models Not stated
- Create derived data Not stated
- Publish results Not stated
What you can share
- Share the data Not stated
- Share derived data Not stated
- Share trained models Not stated
What you must do
- Cite or credit Not stated
- Share alike Not stated
- Sign an agreement Not stated
- Ethics approval Not stated
- Manuscript review Not stated
- Release code Not stated
- Return results Not stated
- Delete after use Not stated
Limits
- No re-identification Not stated
- Location limits Not stated
Citation
Schipke CG, Peters O, Heuser I, Grimmer T, Sabbagh MN, Sabri O, Hock C, Kunz M, Kuhlmann J, Reininger C. Impact of Beta-Amyloid-Specific Florbetaben PET Imaging on Confidence in Early Diagnosis of Alzheimer's Disease. Dement Geriatr Cogn Disord 33:416-422 (2012). doi:10.1159/000339367
Sources
Every number on this page comes from one of these documents. Each chart names the table or page it is taken from. The raw numbers are in stats.csv.